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Jules MOUSSATOFF

Marly-le-Roi

En résumé

Mes compétences :
pharmaceutical industry

Entreprises

  • GlaxoSmithKline - Site Conformance Specialist

    Marly-le-Roi 2015 - maintenant

  • GlaxoSmithKline - Technical (CMC) Regulatory Expert

    Marly-le-Roi 2014 - 2014 Location : GSK Biologicals, Wavre

  • Sanofi Pasteur MSD - Regulatory Affairs Corporate apprentice

    Paris 2012 - 2013 Every assignment is related to a portfolio of vaccines registered under European procedures: Centralised Procedure (CP) or Mutual Recognition Procedure (MRP)
    - Preparation and follow-up of the variations procedure
    - Preparation of the Periodic Safety Update Reports (PSURs) and follow-up of their evaluation by Health Authorities
    - Monitoring the update of the Product Information: Summary of the Product Characteristics (SmPC), patient leaflet and labelling
    - Coordination and follow-up of the linguistic reviews (translation of the Product Information (PI) for the vaccines registered under CP)
    - Regulatory watch: focus on the new pharmacovigilance legislation

  • Gifrer Barbezat - Intern in Regulatory Affairs

    2012 - 2012 - Redaction of a marketing authorization dossier of a medicine (CTD) from 3.2.P.1 to 3.2.P.8
    - Export of a medical device : price fixation, technical certification, cooperation with local health authorities and importer, control of packaging articles and leaflet

  • Grande Pharmacie de la Part-Dieu - Employee in a pharmacy as a confirmed student (over 350 working hours)

    2011 - 2012 - Drugs delivery
    - Responsible for prevention actions

  • Pharmacie des Facultés - Employee in a pharmacy as a confirmed student (over 350 working hours)

    2011 - 2012 - Drugs delivery
    - Responsible for prevention actions
    - Public health promotion

  • Hospices Civils de Lyon - Intern

    Lyon 2011 - 2012 - In charge of articles writing and research work on peripheral neuropathies
    - Responsible for one clinical trial

  • Pharmacie Crom, Saint-Galmier (France) - Employee in a pharmacy as a confirmed student (over 350 working hours)

    2011 - 2012 - Drugs delivery
    - Responsible for prevention actions
    - Public health promotion

  • Faculty of pharmaceutical sciences of Reykjavik - Intern in a research laboratory

    2010 - 2010 - Responsible for research and formulation of pharmaceutical forms suitable for specific uses
    - Report writing and oral presentation of the project before a jury

  • Domicours - Tutor

    2010 - 2012 - Private tuitions for middle school and high school students

  • Hospices Civils de Lyon - Extern

    Lyon 2009 - 2010 - Discovery of preparation and distribution of drugs in a hospital pharmacy
    - Achievement of spectrophotometric quantitative and qualitative controls

Formations

  • EM LYON

    Ecully 2013 - 2013 Marketing, Management

  • IPIL Institut De Pharmacie Industrielle De Lyon

    Lyon 2012 - 2013 M2 Ingénierie pour la Santé et le Mécicament

  • Pharmaceutical Sciences University (ISPB) (Lyon)

    Lyon 2007 - 2013 Pharm. D.

    Pharmaceutical sciences

  • Lycée Francois Mauriac Forez (Andrezieux Boutheon)

    Andrezieux Boutheon 2004 - 2007

Réseau

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